Dinutuximab beta is under clinical development by Recordati and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Dinutuximab beta’s likelihood of approval (LoA) and phase transition for Leiomyosarcoma took place on 22 Apr 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Dinutuximab beta Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Dinutuximab beta overview

Dinutuximab beta (APN-311, Isqette, Qarziba) is a chimeric monoclonal antibody. It is produced in Chinese hamster ovary (CHO) cells. It is formulated as concentrate solution for intravenous route of administration. It is indicated for the treatment of high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with history of relapsed or refractory neuroblastoma, with or without residual disease. Dinutuximab beta Apeiron should be combined with interleukin-2 (IL-2) in patients with a history of relapsed/refractory disease and in patients who have not achieved a complete response after first line therapy.

Dinutuximab beta is under development for the treatment of leiomyosarcoma. It was under development for neuroblastoma in the U.S, Japan and other countries and also for other GD2 indications.

Recordati overview

Recordati, a subsidiary of Fimei SpA, is a pharmaceutical company that researches, develops, manufactures and markets pharmaceuticals. The company offers pharmaceuticals for cardiovascular diseases, central nervous system disorders, dermatology, musculoskeletal disorders and analgesia, and urology diseases. It also offers cosmetics, dietary supplements, pregnancy test products, over-the-counter (OTC) and non-prescription pharmaceuticals, anti-infectives and others. It manufactures pharmaceutical chemicals such as active pharmaceutical ingredients (APIs) and intermediates. The company sells its pharmaceuticals directly in the countries of its operations and through licensees in other places. Recordati is headquartered in Milan, Italy.

Quick View Dinutuximab beta LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Dinutuximab beta
Administration Pathway
  • Intravenous
  • Parenteral
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Recordati
  • Originator: Children’s Cancer Research Institute
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.